38656 Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 / Notices

implementation of this project. For

example, a doctoral degree in economics

or behavioral science with experience in

the design and implementation of largescale data collection processes and

valuation of nonmarketed goods and

services.

b. Evidence of organizational capacity

for large-scale data collection.

c. Evidence of ability to cooperate in

interorganizational and

interdisciplinary settings.

4. Strategic Plan (25 Percent)

a. The objectives of the project are

appropriate, feasible, and timeappropriate for the project.

b. The extent to which the multiple

objectives of the project can be

accomplished within the first year and

how further objectives can be met in

subsequent years.

5. Program Evaluation (10 Percent)

a. The extent to which the applicant

proposes a strategy of ongoing

evaluation and feedback for this project.

b. The adequacy of the applicant’s

plan to evaluate the overall effectiveness

and success of the project.

6. Women and Racial and Ethnic

Minorities in Research (5 Percent)

The extent to which the applicant

addresses that they have met the CDC

Policy requirements regarding the

inclusion of women, ethnic, and racial

groups in the proposed research. This

includes: (a) The proposed plan for the

inclusion of both sexes and racial and

ethnic minority populations for

appropriate representation; (b) The

proposed justification when

representation is limited or absent; (c) A

statement as to whether the design of

the study is adequate to measure

differences when warranted; (d) A

statement as to whether the plans for

recruitment and outreach for study

participants include the process of

establishing partnerships with

community(ies) and recognition of

mutual benefits.

7. Budget (not Scored)

The extent to which the applicant

describes the total amount of funds

requested in each of the object class

categories and clearly links the budget

items to objectives and activities

proposed for the budget period.

8. Human Subjects (not Scored)

The extent to which the applicant has

addressed necessary human subjects

protections.

H. Other Requirements

Technical Reporting Requirements:

Provide CDC with the original plus two

copies of

1. Semi-annual progress reports

including the following for each goal or

activity involved in the study: (a)

Comparison of actual accomplishments

to the objectives established for the

period; (b) the reasons for slippage if

objectives were not met; (c) other

pertinent information including, when

appropriate, analysis and explanation of

unexpectedly high costs for

performance.

2. Financial Status Report is required

within 90 days of each budget period.

3. Final financial status report and

performance report are required within

90 days after the end of the project

period.

Send all reports to: David Elswick,

Grants Management Specialist Grants

Management Branch, Procurement and

Grants Office Centers for Disease

Control and Prevention, (CDC) Room

300, 255 East Paces Ferry Road, NE.,

Mailstop E–13 Atlanta, GA 30305–2209.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment 1, included in the

application kit.

AR98–1 Human Subjects

Requirements

AR98–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR98–9 Paperwork Reduction Act

Requirements

AR98–10 Smoke-Free Workplace

Requirements

AR98–11 Healthy People 2000

AR98–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under the

Public Health Service Act, section

317(k)(2) 42USC247247(b)(k)(2). The

Catalog of Federal Domestic Assistance

number assigned to this project is

93.283.

J. Where To Obtain Additional

Information

To receive additional written

information call 1–888–GRANTS4. You

will be asked to leave your name,

address, and phone number and will

need to refer to Announcement 98103.

You will receive a complete program

description, information on application

procedures, and application forms. CDC

will not send application kits by

facsimile or express mail. PLEASE

REFER TO ANNOUNCEMENT

NUMBER 98103 WHEN REQUESTING

INFORMATION AND SUBMITTING

AN APPLICATION.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained by

contacting:

David Elswick, Grants Management

Specialist, Grants Management

Branch, Procurement and Grants

Office, Announcement 98103

Centers for Disease Control and

Prevention (CDC), Room 300, 255 East

Paces Ferry Road, NE., M/S E–13,

Atlanta, GA 30305–2209, telephone

(404) 842–6521

See also the CDC home page on the

Internet: http://www.cdc.gov.

Programmatic technical assistance

may be obtained from Mark L.

Messonnier, Economist, Prevention

Effectiveness Branch, Division of

Prevention Research and Analytic

Methods, Epidemiology Program Office,

Centers for Disease Control and

Prevention, 1600 Clifton Road, NE.,

Mailstop D–01, Atlanta, Georgia 30333,

telephone (404) 639–4474.

Dated: July 13, 1998.

John L. Williams,

Director, Procurement and Grants Office

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–19074 Filed 7–16–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0291]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; QUADRAMET

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

QUADRAMET and is publishing this

notice of that determination as required

by law. FDA has made the

determination because of the

submission of an application to the

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent which

claims that human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,
Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 / Notices 38657

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6620.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For human drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts

with the initial submission of an

application to market the human drug

product and continues until FDA grants

permission to market the drug product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

a human drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing

the human drug product

QUADRAMET (samarium sm 153

EDTMP). QUADRAMET is indicated

for relief of pain in patients with

confirmed osteoblastic metastatic bone

lesions that enhance radionuclide bone

scan. Subsequent to this approval, the

Patent and Trademark Office received a

patent term restoration application for

QUADRAMET (U.S. Patent No.

4,898,724) from The Dow Chemical Co.,

and the Patent and Trademark Office

requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

November 7, 1997, FDA advised the

Patent and Trademark Office that this

human drug product had undergone a

regulatory review period and that the

approval of QUADRAMET represented

the first permitted commercial

marketing or use of the product. Shortly

thereafter, the Patent and Trademark

Office requested that the FDA determine

the product’s regulatory review period.

FDA has determined that the

applicable regulatory review period for

QUADRAMET is 2,844 days. Of this

time, 2,189 days occurred during the

testing phase of the regulatory review

period, 655 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505 of the Federal Food, Drug,

and Cosmetic Act (the act) became

effective (21 U.S.C. 355): June 16, 1989.

The applicant claims January 28,

1986, as the date the investigational new

drug application (IND) for

QUADRAMET (IND 33,240) became

effective for purposes of regulatory

review period determination. Applicant

also states the notice of clinical

investigation exemption was submitted

on May 16, 1989. However, FDA records

indicate that the IND effective date was

June 16, 1989, which was 30 days after

FDA receipt of IND 33,240.

2. The date the application was

initially submitted with respect to the

human drug product under section 505

of the act: June 13, 1995.

FDA has verified the applicant’s claim

that the new drug application (NDA) for

QUADRAMET (NDA 20,570) was

initially submitted on June 13, 1995.

3. The date the application was

approved: March 28, 1997. FDA has

verified the applicant’s claim that NDA

20,570 was approved on March 28,

1997.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 1,412 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before September 15, 1998, submit

to the Dockets Management Branch

(address above) written comments and

ask for a redetermination. Furthermore,

any interested person may petition FDA,

on or before January 13, 1999, for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. To meet its burden, the petition

must contain sufficient facts to merit an

FDA investigation. (See H. Rept. 857,

part 1, 98th Cong., 2d sess., pp. 41–42,

1984.) Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: June 23, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–19027 Filed 7–16–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Nonprescription Drugs Advisory

Committee: Amendment of Notice

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

amendment to the notice of meeting of

the Nonprescription Drugs Advisory

Committee. This meeting was

announced in the Federal Register of

June 26, 1998 (63 FR 34902). The

amendment is being made to cancel the

entire session on July 28, 1998. There

are no other changes.

FOR FURTHER INFORMATION CONTACT:

Rhonda W. Stover or Angie Whitacre,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–7001, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12541.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 26, 1998 (63 FR

34902), FDA announced that a meeting

of the Nonprescription Drugs Advisory

Committee would be held on July 28

and 29, 1998.

1. On page 34902, in the third

column, the ‘‘Date and Time’’ portion is

amended to read as follows:

Date and Time: The meeting will be

held on July 29, 1998, 8:30 a.m. to 5

p.m.

2. On page 34902, beginning in the

third column, the ‘‘Agenda’’ portion is

amended by removing the first

paragraph.